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Abstract

Introduction: In the TOPCAT trial (N=3445) of heart failure and preserved ejection fraction (HFpEF), marked regional differences were noted in the enrolled populations, event rates, and response to randomized treatment; spironolactone reduced cardiovascular (CV) death and HF hospitalization and increased potassium among those randomized in the Americas. We hypothesized that cardiac biomarker profiles might provide further insight into the observed regional heterogeneity.

Methods: We examined the association between troponin I (hsTNI), C-reactive protein (hsCRP), N-terminal-pro-B-type (NT-proBNP) and B-type Natriuretic Peptide (BNP), soluble ST2 (ST2), uric acid (UA), and urine protein/creatinine ratio (PCR) at baseline and the risk of the primary composite endpoint among 443 TOPCAT subjects with available samples (245 from USA/Canada (NA), 148 from Russia). The effect of spironolactone vs. placebo on the change in biomarker levels from baseline was assessed in 346 subjects with paired follow-up samples available at 12 months.

Results: Median biomarker levels at baseline are summarized below (Table) for the overall cohort and by regions. Marked regional differences were noted in biomarker profile, with significantly higher baseline levels of all biomarkers in subjects enrolled in NA vs. Russia. For the entire cohort, higher baseline levels of any biomarker were correlated with higher risk of the primary endpoint. In the population as a whole, and in NA, treatment with spironolactone reduced NT-proBNP, BNP, and ST2, but not hsTNI, hsCRP, UA, or PCR at 12 months. These effects of randomized treatment on cardiac biomarkers were not apparent among subjects enrolled in Russia.